Premarket Notification for a New Dietary Ingredient

ICR 201905-0910-002

OMB: 0910-0330

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0330 201905-0910-002
Active 201802-0910-011
HHS/FDA CFSAN
Premarket Notification for a New Dietary Ingredient
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 06/11/2019
Retrieve Notice of Action (NOA) 05/08/2019
  Inventory as of this Action Requested Previously Approved
05/31/2021 05/31/2021 05/31/2021
55 0 55
1,100 0 1,100
0 0 0

This information collection supports the premarket notification requirements for a new dietary ingredient (NDI). Respondents include manufacturers, distributors, packagers, holders, labelers, exporters, and importers of dietary supplements that contain NDIs who must report product information to FDA at least 75 days before an NDI or a dietary supplement that contains an NDI can be introduced or delivered into interstate commerce.

US Code: 21 USC 350b(a) Name of Law: null
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  82 FR 54355 11/17/2017
83 FR 13282 03/28/2018
Yes

1
IC Title Form No. Form Name
Reporting - Submission of a Premarket Notification for a New Dietary Ingredient Form FDA 3880

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 55 55 0 0 0 0
Annual Time Burden (Hours) 1,100 1,100 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,416,178
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
05/08/2019


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